MedTech Dive December 8, 2025
An FDA warning letter about the wearable company’s blood pressure feature raises questions about the blurring lines between medtech and wellness.
Sometimes, the line between medical and wellness products can blur. Regulators’ pushback on a blood pressure feature that Whoop incorporated into its wellness wristband illustrates the challenges wearables developers face as they add increasingly sophisticated features.
Whoop received a warning letter from the Food and Drug Administration this summer after rolling out the blood pressure offering without regulatory authorization.
The company has pushed back on the warning letter, however, arguing that blood pressure is a wellness feature. The FDA disagreed, saying blood pressure is inherently related to a medical diagnosis.
The FDA isn’t likely to concede on its...
Today's Sponsors
Today's Sponsor